History
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2025
- REGENECYTE (HPC, Cord Blood) received the 2025 Taiwan BIO Awards — Innovation of the Year.
- Phase I clinical trial results of cord blood therapy for acute ischemic stroke were published in the Tzu Chi Medical Journal.
2024
- U.S. FDA and Taiwan TFDA approved a Phase II clinical trial of cord blood therapy for acute ischemic stroke.
- Taiwan TFDA approved a Phase I clinical trial of cord blood therapy for cerebral palsy.
- REGENECYTE received U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) designation.
- Phase II clinical trial results of REGENECYTE for long COVID were publicly disclosed: 85% of patients experienced complete resolution of fatigue after treatment, meeting the efficacy endpoint.
- REGENECYTE received U.S. FDA approval of its Biologics License Application (BLA).
2023
- U.S. FDA authorized initiation of patient enrollment for a Phase II clinical trial of cord blood REGENECYTE for long COVID.
- The Taiwan TFDA–approved Phase I clinical trial of cord blood therapy for acute ischemic stroke has completed all study visits.
- A case report combining cord blood REGENECYTE with peripheral blood stem cells to treat HIV and acute leukemia was published in the top-tier international journal Cell.
- In collaboration with Taichung Veterans General Hospital, completed a clinical case using sibling-derived mesenchymal stem cells to treat hypoxic–ischemic encephalopathy.
2022
- REGENECYTE (HPC, Cord Blood) therapy for hematologic disorders, has submitted a Biologics License Application (BLA) to the U.S. FDA.
- In collaboration with Taipei Medical University, the world’s first clinical case of administering three units of cord blood to an adult patient with cerebral palsy has been successfully completed.
2021
- Case-based results from a Phase I clinical trial of cord blood therapy for acute ischemic stroke were published in the international medical journal Cell Transplantation.
- The U.S. FDA and Taiwan TFDA authorized initiation of enrollment for a multinational, multicenter Phase II clinical trial of MC001 for chronic spinal cord injury.
2019
- The Taiwan TFDA has approved the initiation of patient enrollment for a Phase I clinical trial of “Cord Blood Therapy for Acute Ischemic Stroke.”
2016
- The results of the Phase I/II clinical trials of MC001 for the treatment of chronic spinal cord injury have been published in the international medical journal Cell Transplantation.
2015
- A total of 2,000 cord blood transplants have been successfully facilitated worldwide.
2014
- A Phase I/II clinical trials of “MC001 for the Treatment of Chronic Spinal Cord Injury” have been completed.
2013
- StemCyte is incorporated in the Cayman Islands.
- StemCyte USA is participating in the NIH-led international HIV clinical trial collaboration, IMPAACT P1107
- The Taiwan Ministry of Economic Affairs Industrial Development Bureau has approved StemCyte Taiwan as a technology enterprise.
2012
- Completed a Phase II clinical trial using autologous peripheral blood stem cells to treat chronic stroke.
- StemCyte Taiwan obtained accreditation from the Foundation for the Accreditation of Cellular Therapy (FACT).
2010
- Conducted Phase I/II clinical trials in Hong Kong and China of MC001, a cord blood investigational therapy for chronic spinal cord injury.
2009
- StemCyte USA Laboratory has obtained accreditation from the American Society for Histocompatibility and Immunogenetics (ASHI).
2007
- Successfully facilitated Taiwan’s first private cord blood transplant, in which a younger brother’s donation saved his older brother.
- Ranked 6th among the top 50 fastest-growing technology companies in the Los Angeles area by Deloitte.
2006
- U.S. StemCyte obtained accreditation from the Foundation for the Accreditation of Cellular Therapy (FACT).
- U.S. StemCyte was commissioned by the U.S. Health Resources and Services Administration (HRSA) to support the National Cord Blood Inventory (NCBI) collection program.
2005
- Successfully facilitated cord blood transplants that cured 12 children with β- thalassemia, leading to a special approval by Taiwan’s Department of Health recognizing cord blood transplantation as a standard legal treatment for hematologic disorders.
- Supported Taiwan’s first successful cord blood transplant for the treatment of osteopetrosis (Marble Bone Disease).
- Assisted in Taiwan’s first cord blood transplant for a baby under two months old, setting a record as the youngest successful case.
2004
- Assisted in the successful completion of Taiwan’s first multi-unit cord blood transplantation to treat leukemia.
- Assisted in the successful completion of Taiwan’s first cord blood transplantation to treat severe combined immunodeficiency (SCID).
- StemCyte Taiwan obtained AABB (Association for the Advancement of Blood & Biotherapies) accreditation.
2003
- Successfully facilitated Taiwan’s first cord blood transplant for the treatment of β- thalassemia major.
2002
- U.S. StemCyte obtained AABB (Association for the Advancement of Blood & Biotherapies) accreditation.
- Taiwan StemCyte provided its first cord blood unit to Singapore for transplantation.
- Became one of the world’s major public cord blood banks, with an inventory exceeding 20,000 units.
2001
- Initiated the collection of publicly donated cord blood in Taiwan.
2000
- Started collecting and providing cord blood in California, USA.
- Established StemCyte Taiwan.
1998
- Developed cord blood storage technology and established standard operating procedures (SOP) for cord blood banking.
1997